Medical device recalls
Device recalls are the largest single group in this archive, because the FDA logs corrections and removals as well as outright withdrawals. Many are handled entirely between the manufacturer and a hospital and need nothing from a patient. Each notice states who has to act.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Oct 16, 2024
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
FDA (openFDA device enforcement)
Reported Oct 16, 2024
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Oct 16, 2024
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
FDA (openFDA device enforcement)
Reported Oct 16, 2024
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Qualigen Inc.
FDA (openFDA device enforcement)
Reported Oct 16, 2024
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quantum Surgical Sas
FDA (openFDA device enforcement)
Reported Oct 16, 2024
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
FDA (openFDA device enforcement)
Reported Oct 16, 2024
Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 16, 2024
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Zyno Medical LLC
FDA (openFDA device enforcement)
Reported Oct 9, 2024
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
FDA (openFDA device enforcement)
Reported Oct 9, 2024
BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton, Dickinson and Company, BD Bio Sciences
FDA (openFDA device enforcement)
Reported Oct 9, 2024
BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperVision, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 9, 2024
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Feng Chun Yuan Medical Equipment (shenzhen)co.,Ltd.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 9, 2024
Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Healgen Scientific LLC
FDA (openFDA device enforcement)
Reported Oct 9, 2024
MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic MiniMed, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 9, 2024
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Mercury Enterprises, Inc. dba Mercury Medical
FDA (openFDA device enforcement)
Reported Oct 9, 2024
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur H / F
FDA (openFDA device enforcement)
Reported Oct 9, 2024
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Outset Medical, Inc.
FDA (openFDA device enforcement)
Reported Oct 9, 2024
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
High riskUsing this product could cause serious injury, illness or death — stop using it now.Percussionaire Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 9, 2024
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Oct 9, 2024
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
FDA (openFDA device enforcement)
Reported Oct 9, 2024
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 9, 2024
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tornier, Inc.
FDA (openFDA device enforcement)
Reported Oct 9, 2024
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Young Dental Manufacturing I, LLC
FDA (openFDA device enforcement)
Reported Oct 2, 2024
PACEMAKER PACK, SLCV01J; Medical convenience kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
18 more products in this recall
FDA (openFDA device enforcement)
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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.